Audits are the central tool for checking compliance with the normative, regulatory and internal requirements placed on the quality management system.

The ISO 19011 standard is a general guide to auditing quality management systems. In addition to instructions for auditing, ISO 19011:2018 describes the control of an audit program and the assessment of the auditor’s competence. This general standard is applicable to all organizations that perform internal and external audits of management systems or are responsible for the management of an audit program.

The audit itself is defined in ISO 19011:2018 as a systematic, independent and documented process for obtaining audit evidence and its objective evaluation to determine to what extent the audit criteria are met.

ISO 19011 distinguishes between the following audits:

  • Internal audits („first-party audits”)
  • External supplier audits (“second-party audits”)
  • External audits for regulatory purposes, such as a certification audit by a notified body („third-party audits“)

The execution of an audit is a matter of thorough preparation and planning. A risk-based approach considers risks of the audit activities regarding the processes of the audited organization. Audit planning includes but is not limited to the audit objectives, audit scope, audit criteria, locations, responsibilities and audit method.

During the audit, a reasonable number of samples should be collected as audit evidence. Based on the audit criteria, the evidence is evaluated, and corresponding audit findings are derived. Non-conformities can be classified accord-ing to the context of the organization and its risks. The results of the audit are documented in an audit report. Depending on the outcome of the audit, audit follow-up measures are carried out. Such measures are usually decided and executed by the audited organization within an agreed timeframe.

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